RecruitingPhase 2NCT03727633
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.
Sponsor
University Hospital, Montpellier
Enrollment
53 participants
Start Date
Jul 19, 2018
Study Type
INTERVENTIONAL
Conditions
Summary
The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
Eligibility
Min Age: 18 Years
Inclusion Criteria14
- Histologically-proven HCC or according to EASL criteria
- Child-Pugh A or B7
- Disease that is not suitable for resection, ablation or radiofrequency
- Performance Status ECOG 0 or 1
- BCLC A/B or C if Performance Status ECOG = 1
- Measurable lesions according to mRECIST criteria
- No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
- Age superior or equal to 18 years
- Platelets \> 50,000/mm3, Polynuclear neutrophils \> 1000/mm3, Creatininemia \< 150umol/L, Bilirubinemia \< 5 mg/dL
- Absence of heart failure (Ultrasound LVEF \> 50%)
- Women of child-bearing age using an adequate method of contraception throughout treatment
- Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment
- Written informed consent
- National health insurance cover
Exclusion Criteria15
- Advanced tumor disease (extrahepatic except pulmonary micronodules \<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
- Large HCC with liver invasion \>50%
- History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose
- Advanced liver disease (Child B8, B9 or C)
- Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
- Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
- Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)
- Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
- Concomitant disease or uncontrolled severe clinical situation
- Uncontrolled severe infection
- Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
- Pregnancy (Beta HCG positive) or breastfeeding
- Patient who for psychological, social, family or geographical reasons cannot be followed regularly
- Vulnerable person
- Concomitant participation of the patient in another research involving the human person
Interventions
DRUGIdarubicin and Lipiodol
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03727633
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